Medical Device Registration in Korea for Overseas Manufacturers — the 7-Step MFDS Approval Path

Key takeaway — Getting an imported medical device onto the Korean market takes seven steps: ① confirm whether it is a medical device under Korean rules and which class, ② decide which importer will hold the licence, ③ assemble the technical file, test data, and quality-system data the manufacturer must supply, ④ obtain KGMP conformity recognition, overseas manufacturing site included, ⑤ obtain the item notification, certification, or licence for the class, ⑥ prepare Korean-language labels and package inserts, and ⑦ carry out post-market reporting, recall, and renewal duties. FDA, CE, and MDSAP documents do not let you skip any of this; they feed into step ③. Depending on the class the path takes months to more than a year, and the most common cause of delay is signing a distribution agreement before steps ② and ③ are done.

Step 1 — Confirm the Korean classification

Korea classifies devices by intended use and potential risk under a designation made by the MFDS (Medical Devices Act, Article 3); the specific items and classes are listed in the annex to an MFDS notification. There are four classes, and the procedure splits by class into notification (Class 1), certification (Class 2), and licence (Class 3 and 4) (Article 6(2), Article 15(2)). Overseas classes do not always map onto Korean ones, so do not assume that an EU Class IIa device is Korean Class 2 — find the Korean item code first. How to find it is in finding your item classification and class, and the procedural differences by class are in the procedure overview.

In vitro diagnostic devices have been governed by their own statute since 2020, with a different basis for classification and different names for the clinical evidence — start with the IVD guide. The rest of this article covers general medical devices.

Step 2 — Decide who will hold the licence

An import licence in Korea is issued in the name of an importer holding an import business licence, not in the manufacturer's name (Article 15(1) and (2)). The importer must have quality-inspection facilities and a quality management system in Korea (Article 15(4)) and a quality manager (Article 6(7), applied through Article 15(6)). A manufacturer without a Korean entity chooses between a subsidiary, a distributor that also acts as importer, and an independent licence holder (ICC) — and that choice determines whether the partner can later be replaced. The three structures and the contract clauses that go with them are covered in the KLH and ICC structure guide.

Skip this step and sign a distribution agreement first, and every document from step 3 onward is filed in the distributor's name — and the licence stays there. Settle it before the registration starts.

Step 3 — Assemble what the manufacturer must supply

To obtain an item licence or certification, or file a notification, the importer must submit quality management system data, the technical file, clinical data, and other required materials to the MFDS (Article 6(5), applied through Article 15(6)). The source of all of it is the manufacturer. However prepared the Korean importer or consultant may be, the registration stops when the manufacturer does not release the documents.

Material	Legal basis	What the manufacturer provides
Technical file	Article 2(2) — a document covering raw materials, structure, intended use, directions for use, mechanism of action, precautions, and test specifications	Design specifications, bill of materials, drawings, original labels and manuals, test specifications
Test reports	Tests against the applicable standards (Article 19)	Electrical safety, EMC, biocompatibility, and performance test reports. How far foreign reports are accepted: foreign test reports guide
Clinical data	Article 10 (approval of clinical trial plans) — only for items that require it	Existing clinical literature and overseas clinical data. Whether a Korean trial is needed: clinical trial guide
Quality management system data	Article 28	Quality manual, procedures, manufacturing site information, ISO 13485 certificate where held

The conformity review of the technical file may be carried out by a technical document review body designated by the MFDS (Article 6-4). Item-by-item guidance is in the technical file guide, and what to fix before ordering tests is in ISO 10993 biological evaluation and ISO 14971 risk management.

Step 4 — Obtain KGMP conformity recognition

Applicants for and holders of an import business licence must have their manufacturing and quality management system reviewed by the MFDS and obtain conformity recognition (Article 28(1)). The review covers the overseas manufacturing site, and material changes such as a change in that site's location trigger a fresh review. The certificate is valid for three years from issue (Article 28(3)) and must be renewed before expiry to remain in force (Article 28(4)). The review may be carried out by a quality-system audit body designated by the MFDS (Article 28-3).

The question overseas manufacturers ask most often is why a KGMP audit is needed when they already hold ISO 13485. The certificate is used as audit evidence but does not replace conformity recognition against the Korean notification — what is the same and what differs is in ISO 13485 vs KGMP, and handling an overseas site audit is in the KGMP conformity guide. Most Class 1 devices fall outside conformity recognition, with exceptions such as sterile products (when Class 1 still needs KGMP).

Step 5 — Obtain the item notification, certification, or licence

At least one item must be filed together with the import business licence application (Article 15(3)); each additional item then goes through its own procedure. The decision on the import business licence is notified within 25 days of the application (Article 6(8), applied through Article 15(6)). Processing periods and statutory fees for the item review differ by class and are summarized in timelines and costs.

A newly developed device whose mechanism of action or raw materials are entirely new may be licensed on condition of post-market surveillance for four to seven years (Article 8(1)). A licence, certification, or notification is valid for five years and must be renewed to continue importing (Article 49) — see the renewal guide.

Step 6 — Prepare Korean labels and package inserts

The container or outer casing must carry the statutory items (Article 20), the outer packaging (Article 21) and package insert (Article 22) complete the set, and Korean-language marking is the rule (Article 23). A configuration that simply affixes the manufacturer's original label does not stand. The right time for this work is immediately after approval and before the packaging order, and the items — and the ones most often missed — are in the labeling guide. The importer's name and address on the label follow the licence holder decided in step 2.

Step 7 — Post-market duties begin

Approval is a beginning, not an end. Any handler of a medical device who becomes aware of a death or serious adverse event during use must report it immediately, and manufacturers and importers must recall a product without delay when it poses a risk of harm and report a recall plan in advance (Article 31(1) and (2)). On top of that come UDI registration and supply reporting, the five-year renewal, and the three-year KGMP re-audit. The full list is in what starts after approval. These duties belong to the importer by law, so the structure chosen in step 2 comes back into play here — who performs them and who pays must be in the contract.

Where your overseas approvals fit

What you hold	Role in the Korean registration
FDA 510(k) or PMA, CE (MDR) certificate	Does not replace the review. Source material for the technical file and for demonstrating equivalence
Foreign test reports (IEC 60601, ISO 10993, etc.)	Tests may be waived and data used within the accepted scope — the scope must be checked first
ISO 13485 certificate	Evidence for the KGMP audit. Does not replace conformity recognition itself
MDSAP audit report	Used in preparing for the KGMP audit — MDSAP guide
Overseas clinical data	Reviewed as clinical evidence. Whether a Korean trial is needed depends on the item and the data

Korea does not run a route that recognizes overseas approvals to shorten its review; what it examines is whether a complete set of documents meeting Korean requirements exists. More on this in does CE certification get you Korean approval?.

Common mistakes

• Signing the distribution agreement first — sign before step 2 and the licence is fixed in the distributor's name
• Treating overseas certificates as the finish line — a certificate is evidence, not an approval
• Checking Korean requirements after testing is complete — where the standards differ, that means retesting. Confirm the Korean standards before you order
• Leaving KGMP until after the item review — the import business licence and the item procedure do not complete without conformity recognition
• Starting labels on the eve of customs clearance — repackaging costs and schedule delays arrive together
• Leaving post-market costs out of the contract — adverse event reporting, recalls, and renewals continue for as long as the product is on the market

Before you start

• You have confirmed the Korean item code and class (not inferred from the overseas class)
• You have decided the licence holder (importer) and the structure
• You have listed the technical file, test reports, and quality-system data and marked what is missing
• You have checked the accepted scope of your foreign test reports
• You have scheduled the KGMP audit of the overseas manufacturing site
• Korean labeling and package inserts are scheduled before the packaging order
• The party performing and the party paying for post-market duties are in the contract

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Of the seven steps, the ones the manufacturer controls are the structure in step 2 and the documents in step 3. Send us the product specification, a list of the approvals and test reports you hold, and your Korean sales plan, and we will tell you within one business day which class applies, what is missing, and which structure fits — through a free pre-review.

Legal basis: Medical Devices Act of Korea (Act No. 21949, in force 15 Sep 2026) — Article 2 (Definitions) · Article 3 (Classification and Designation of Classes) · Article 6 (Licence for Manufacturing Business, etc.) · Article 6-4 (Designation of Technical Document Review Bodies, etc.) · Article 8 (Post-Market Surveillance of Newly Developed Devices, etc.) · Article 10 (Approval of Clinical Trial Plans, etc.) · Article 15 (Licence for Import Business, etc.) · Articles 20–23 (Markings) · Article 28 (Conformity Recognition of Manufacturing and Quality Management Systems) · Article 28-3 (Designation of Conformity Recognition Bodies, etc.) · Article 31 (Management of Adverse Events) · Article 49 (Renewal of Manufacturing Licences, etc.). Texts confirmed on 22 Sep 2026 in the National Law Information Center. Processing periods and fees by class follow the Ordinance and notifications; the content may change as the legislation is amended.